A Comparative Study Between Two Formulations of the Ciprofloxacin Hydrochloride + Hydrocortisone Otic Suspension
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|ClinicalTrials.gov Identifier: NCT00980876|
Recruitment Status : Completed
First Posted : September 21, 2009
Last Update Posted : April 17, 2015
|Condition or disease||Intervention/treatment||Phase|
|Otitis Externa||Drug: Cipro HC Drug: Ciprofloxacin HCl and Hydrocortisone||Phase 3|
Phase III, non inferiority, multicentric, controlled, single blind, parallel-group, randomized study.
Population: 224 patients with external otitis , men and women aged between 1 - 70 years.
Primary endpoint: The primary endpoint of this study is the elimination of pain, swelling and otorrhea (cure).
Secondary endpoint: The endpoint will be the identification of the side effects of medication use.
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||224 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Double (Participant, Investigator)|
|Official Title:||Multicentric, Double Blind, Randomized, Parallel Comparative Study Between Ciprofloxacin HCl 2 mg/mL + Hydrocortisone 10 mg/mL Ear Suspension and Cipro HC®, for the Assessment of Efficacy and Safety in Patients With Otitis Externa.|
|Study Start Date :||April 2012|
|Primary Completion Date :||January 2015|
|Study Completion Date :||January 2015|
Active Comparator: Cipro HC
Drug: Cipro HC
Cipro HC (Ciprofloxacin HCl and Hydrocortisone)
Experimental: Ciprofloxacin HCl and Hydrocortisone
Drug: Ciprofloxacin HCl and Hydrocortisone
Ciprofloxacin Hydrochloride and Hydrocortisone
Other Name: Otociriax
- Cure (reduced pain, swelling and otorrhea) [ Time Frame: 7 days ]
- Identification of possible side effects [ Time Frame: 7 days ]
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00980876
|Campinas, São Paulo, Brazil, 13087-000|
|Principal Investigator:||Agricio N. Crespo, Phd||Clínica Quiron|